FDA accepts two NDAs from Merck for Priority Review: February’s industry headlines


Take a look at this month’s industry headlines including Priority Review for two antibacterial agents from Merck (NJ, USA), a clinical trial for a new malaria drug and the launch of omadacycline in the USA.

FDA accepts two NDAs from Merck for Priority Review

The US FDA has accepted to review two regulatory filings for antibacterial agents being developed by Merck.

The first of these two filings is a New Drug Application (NDA), accepted for Priority Review, for the combination of beta-lactamase inhibitor relebactam with imipenem/cilastatin to treat complicated urinary tract infections and complicated intra-abdominal infections in adults with limited or no alternative therapies available. The NDA for imipenem/cilastatin/relebactam was based on the results of the Phase III trial RESTORE-IMI1.

Find out more about the RESTORE-1 trial, results and real-world repercussions in out interview with Principal Investigator, Keith Kaye >>

A supplemental NDA was also accepted for the Priority Review of ceftolozane/tazobactam (ZERBAXA®) to treat adults with nosocomial pneumonia, including ventilator-associated pneumonia caused by susceptible Gram-negative microorganisms.

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SGS conducting first malaria human challenge trial

SGS (Geneva, Switzerland) has announced it will commence its first volunteer infection study in Belgium in February 2019 on behalf of Medicines for Malaria Venture (MMV; Geneva, Switzerland).

The primary objective of the trial is to test the efficacy of MMV’s experimental compound in killing malaria parasites in the liver before they can develop and reach the bloodstream. The trial will be conducted in SGS’s dedicated 20-bed unit at Antwerp’s Stuivenberg Hospital (Belgium) under a high level of safety and supervision.

Timothy Wells, MMV’s Chief Scientific Officer, commented: “MMV and its partners have taken a leadership role in finding new ways to accelerate the development of new medicines to treat and prevent malaria. The compound has demonstrated potential to target malaria parasites before they have a chance to establish the symptoms of malaria, and therefore could help protect children from getting sick. In collaboration with SGS this potential will be tested in human subjects for the first time.”

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Amprologix receives funding to scale-up antibiotic candidate

Amprologix (Plymouth, UK) has been awarded a £1.2 million contract from the UK Department of Health and Social Care to accelerate the development and scale up its lead antibiotic candidate, Epidermicin NI01. The funding, from Innovate UK, is intended to advance Epidermicin NI01 – a potential new class of antibiotic – with the aim of entering Phase I clinical trials by early 2021.

CSO Matthew Upton commented: ““Epidermicin has excellent potential for use in nasal decolonisation to prevent skin and wound infections, like those caused by MRSA. Development of NI01 could have immense benefits for patients, so I’m genuinely excited about this work and generating the data needed to enter Phase I trials.”

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FDA approval for Phase III clinical trial of SPR994 in cUTI

The FDA has accepted an Investigational NDA for Spero Therapeutics’ (MA, USA) SPR994, a candidate being developed as an oral carbapenem for the treatment of complicated urinary tract infections. The company can now initiate enrollment of a Phase III clinical trial in the USA.

“With the FDA’s acceptance of our Investigational NDA for SPR994, we are excited to continue our Phase III initiation efforts, including opening clinical trial sites for enrollment in the USA,” commented Ankit Mahadevia, Chief Executive Officer of Spero Therapeutics. “We look forward to enrolling patients in our single pivotal Phase III clinical trial with the hope, following approval, of providing patients with the option for an oral carbapenem to address the serious unmet need of multi-drug resistant infections.”

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Paratek Pharmaceuticals launch NUZYRA™ (omadacycline) in the United States

Paratek Pharmaceuticals (MA, USA) has announced the commercial availability of NUZYRA (omadacycline) in the USA.  NUZYRA, a modernized tetracycline, is a once-daily oral and intravenous antibiotic for adults with community-acquired bacterial pneumonia and acute skin and skin structure infections.

Paratek also plans to provide additional tools that will allow more clarity in the decision-making matrix that physicians utilize when prescribing antibiotics, including three antimicrobial susceptibility tests and the KEYSTONETM Surveillance Program. These tools will be available in concert with the commercial launch of NUZYRA.

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